Catalog Number

77-401111

Brand Name

DeRoyal

Version/Model Number

77-401111

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DXT

Product Code Name

INJECTOR AND SYRINGE, ANGIOGRAPHIC

Public Device Record Key

1920cd88-ec0e-4e24-9c5c-367daab5b5e1

Public Version Date

August 09, 2019

Public Version Number

1

DI Record Publish Date

August 01, 2019

Package DI Number

50749756992539

Quantity per Package

5

Contains DI Package

00749756992534

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case